RHEUMAJET RF

System, Test, Rheumatoid Factor

BIOKIT USA, INC.

The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for Rheumajet Rf.

Pre-market Notification Details

Device IDK910539
510k NumberK910539
Device Name:RHEUMAJET RF
ClassificationSystem, Test, Rheumatoid Factor
Applicant BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
ContactIgnacio Odriozola
CorrespondentIgnacio Odriozola
BIOKIT USA, INC. CAN MALE LLISSA D'AMUNT Barcelona,  ES 08186
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-28
Decision Date1991-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613647001295 K910539 000
00613647001264 K910539 000
00613647001257 K910539 000

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